Safe needle methods, apparatus, and systems

ABSTRACT

A bandage can be used to secure a needle to an access site so as to prevent unintended movement or withdrawal of the needle from the access site during administration of a treatment to a patient. After treatment, the needle can be removed by manipulating a portion of the bandage. Another portion of the bandage can be maintained in position over the access site during needle removal and can be used to promote clotting of the site after needle removal. The bandage may include a clotting agent, a hemostasis pad, and/or a clot-promoting structure. Additionally or alternatively, finger pressure can be applied to the access site through the bandage. For example, the bandage may include a viewing window without any adhesive to allow visual monitoring of the access site during treatment. Finger pressure may be applied to the viewing window and thereby to the access site during and after needle removal to encourage hemostasis.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of U.S. ProvisionalApplication No. 61/348,695, filed May 26, 2010, and U.S. ProvisionalApplication No. 61/354,645, filed Jun. 14, 2010, both of which arehereby incorporated by reference herein in there entireties.

FIELD

The present disclosure relates generally to needles for intravenous orsubcutaneous insertion into a patient, and, more particularly, to safetymethods, apparatuses, and systems for securing and protecting a needleinserted into an access site of the patient. The present disclosure alsorelates to bandages and methods for using bandages to secure a needlewhen inserted into an access site of a patient and to promote clottingafter removal of the needle from the access site.

SUMMARY

A bandage of flexible material can resist extraction of a needle, suchas a butterfly needle, when it has been inserted into a patient accesssite. A first portion of the bandage can be releasably attached to wingsof the butterfly needle. A second portion of the bandage includes anadhesive that holds the needle to the skin. When attached to the needle,the arrangement of the first and second portions of the bandage preventsthe needle from moving away from the access site when the bandage isapplied to the patient. The first portion may be attached to theback-side of wings of the needle hub with the bandage looping over thefront-side of the wings and extending to the second portion, which isattached to the skin of the patient. Once treatment is completed, thefirst portion may be released from the wings by pulling on an endportion of the bandage adjacent to the first portion. After the firstportion is released, the bandage is no longer attached to the butterflyneedle such that the needle can be removed from the access site whilethe second portion of the bandage remains in place. The bandage caninclude a hemostasis pad over the access site to encourage clottingafter needle removal. Alternatively or additionally, the bandage caninclude a viewing window over the access site to allow for viewing ofthe access site during treatment.

Looping a portion of the bandage over the front side of the wings tosecure the needle to the access site can also be achieved usingdifferent bandage configurations. For example, the bandage may beconfigured as two strips of medical tape. A portion of the tape can beadhered to the back-side of the wings of the needle with the remainingportion of the tape extending away from the needle tip and the accesssite. The remaining portions of the tape can be looped back over thefront-side of the wings (toward the needle tip and access site) andadhered to portions of the skin adjacent to or at least proximal to theaccess site.

In some embodiments, a needle securing device can be used to secure theneedle in the patient access site. The bandage and/or tape can beapplied to the securing device to attach it to the patient's skin in asecure manner. For example, the bandage can be configured as two stripsof medical tape. When the securing device is a wedge-shaped securingdevice, a portion of the tape can be adhered to the skin-adjacent-sideof the securing device with the remaining portion of the tape extendingaway from the needle tip and the access site. The remaining portions ofthe tape can be looped back over the top-side of the securing device aswell as the front-side of the wings (toward the needle tip and accesssite). This remaining portion can then be adhered to portions of theskin adjacent to or at least proximate to the access site to secure boththe securing device and the needle to the patient.

In addition, aspects of the disclosed subject matter may be applied tosecuring needles to a patient access site with a bandage and to allowingremoval of the needle by manipulating the bandage. Clotting of thepatient access site can be encouraged by applying pressure through thebandage to the patient access site. For example, a first portion of thebandage can include a viewing window that is positioned over the patientaccess site. The viewing window can be provided without any adhesive,but can be surrounded by a region with adhesive thereon. Alternativelyor additionally, the window can include a clot promoting component, suchas, but not limited to, a clotting agent, a hemostasis pad, and aprotruding bubble portion filled with air. A second portion of thebandage can secure the needle to the skin of the patient during use ofthe needle, for example, to effect a treatment. After treatment, thesecond portion may be disengaged from the skin to allow removal of theneedle from the patient access site. Finger pressure can be applied tothe viewing window during needle removal, after which at least theadhesive region of the first portion is secured to the patient skinwhile pressure is maintained to promote hemostasis.

In embodiments, a bandage can secure a butterfly needle to a patientaccess site. The needle can have a pair of wings extending radially fromthe hub of the needle. The bandage can be a flexible material having afirst region, a second region, and a third region. The first region canhave a first adhesive on at least a surface portion thereof. The secondregion can have a gap therein so as to form a pair of tabs separated bythe gap. The tabs may be free from any adhesive. The third region can bearranged between the first and second regions and can have a secondadhesive on at least a surface portion thereof. The bandage can furtherinclude a hemostasis pad arranged in the first region. The hemostasispad may be constructed to promote clotting of blood that contacts saidpad. The third region can be arranged so as to contact the pair of wingsof the butterfly needle for releasably coupling the bandage thereto. Thehemostasis pad can be arranged so as to contact the patient access sitewhen the third region is coupled to the butterfly needle.

In embodiments, a needle assembly can include a butterfly needle havinga tip, a hub with a pair of wings extending radially therefrom, andtubing extending from the hub and in fluid communication with the tip.The needle assembly may further include a bandage for securing thebutterfly needle to a patient access site when the needle is insertedtherein. The bandage can have a first end region, a second end region,and a middle region between the first and second end regions. The firstend region can have a first adhesive on at least a portion thereof and ahemostasis pad. The second end region can be without any adhesive. Themiddle region can be releasably connected to the pair of wings by asecond adhesive on at least a portion of the middle region. The firstend region can be arranged so as to releasably connect to a patient'sskin with the hemostasis pad adjacent to a patient access site when thebutterfly needle is inserted into the patient access site.

In embodiments, a kit for connecting to a patient access can include abutterfly needle and a bandage. The butterfly needle can include a tip,a hub with a pair of wings extending radially therefrom, and tubingextending from the hub and in fluid communication with the tip. Thebandage can be a flexible material having a first region, a secondregion, and a third region. The first region can have a first adhesiveon at least a surface portion thereof. The second region can have a gaptherein so as to form a pair of tabs separated by the gap. The tabs maybe free from any adhesive. The third region can be arranged between thefirst and second regions and can have a second adhesive on at least asurface portion thereof. The bandage can further include a hemostasispad arranged in the first region. The hemostasis pad may be constructedto promote clotting of blood that contacts said pad. The third regioncan be arranged so as to contact the pair of wings of the butterflyneedle for releasably coupling the bandage thereto. The hemostasis padcan be arranged so as to contact the patient access site when the thirdregion is coupled to the butterfly needle.

In embodiments, a bandage can secure a butterfly needle to a patientaccess site. The needle can have a pair of wings extending radially fromthe hub of the needle. The bandage can be a flexible material having afirst region, a second region, and a third region. The first region canhave a first adhesive on at least a surface portion thereof and awindow. The window in the first region can be transparent and withoutany adhesive thereon. The second region can have a gap therein so as toform a pair of tabs separated by the gap. The tabs can be free from anyadhesive. The third region can be arranged between the first and secondregions and can have a second adhesive on at least a surface portionthereof. The third region can be arranged so as to contact the pair ofwings of the butterfly needle for releasably coupling the bandagethereto. The window can be arranged so as to be located over the patientaccess site when the third region is coupled to the butterfly needleinserted into said access site.

In embodiments, a method for connecting to a patient access site with abutterfly needle can include affixing a bandage to wings of thebutterfly needle. The butterfly needle can include a tip, a hub with apair of wings extending radially therefrom, and tubing extending fromthe hub and in fluid communication with the tip. The bandage can be aflexible material having a first region, a second region, and a thirdregion. The first region can have a first adhesive on at least a surfaceportion thereof. The second region can have a gap therein so as to forma pair of tabs separated by the gap. The tabs may be free from anyadhesive. The third region can be arranged between the first and secondregions and can have a second adhesive on at least a surface portionthereof. The bandage can further include a hemostasis pad arranged inthe first region. The hemostasis pad may be constructed to promoteclotting of blood that contacts said pad. The third region can beaffixed to the pair of wings of the butterfly needle for releasablycoupling the bandage thereto. The hemostasis pad can be arranged so asto contact the patient access site when the third region is coupled tothe butterfly needle.

The method can further include inserting the tip of the butterfly needleinto the patient access site and affixing the first region onto skin ofthe patient proximal to the patient access site. The method can alsoinclude, after the inserting, removing the third region of the bandagefrom the wings of the butterfly needle. The method can further includeremoving the tip of the butterfly needle from the patient access sitewhile contacting the hemostasis pad with the patient access site.

In embodiments, a method for connecting to a patient access site with abutterfly needle can include affixing a bandage to wings of thebutterfly needle. The butterfly needle can include a tip, a hub with apair of wings extending radially therefrom, and tubing extending fromthe hub and in fluid communication with the tip. The bandage can be aflexible material having a first region, a second region, and a thirdregion. The first region can have a first adhesive on at least a surfaceportion thereof and a window. The window in the first region can betransparent and without any adhesive thereon. The second region can havea gap therein so as to form a pair of tabs separated by the gap. Thetabs can be free from any adhesive. The third region can be arrangedbetween the first and second regions and can have a second adhesive onat least a surface portion thereof. The third region can be affixed tothe pair of wings of the butterfly needle for releasably coupling thebandage thereto. The window can be arranged so as to be located over thepatient access site when the third region is coupled to the butterflyneedle inserted into said access site.

The method can further include inserting the tip of the butterfly needleinto the patient access site and affixing the first region onto skin ofthe patient such that the window overlays the patient access site. Themethod can also include, after the inserting, removing the third regionof the bandage from the wings of the butterfly needle. The method canalso include removing the tip of the butterfly needle from the patientaccess site while said first region of the bandage remains affixed tothe skin.

In embodiments, a bandage can secure a butterfly needle to a patientaccess site. The needle can have a pair of wings extending radially fromthe hub of the needle. The bandage can be a pair of strips of flexiblematerial. Each strip can have a first region, a second region, and athird region. The first region can have an adhesive on at least asurface portion thereof. The second region can also have an adhesive onat least a surface portion thereof. The second region can be arranged soas to contact a front surface of the one of the pair of wings of thebutterfly needle. The third region can be arranged between the first andsecond regions and to contact a back surface of one of the pair of wingsof the butterfly needle. The first region can be arranged so as tocontact skin adjacent the patient access site when the second and thirdregions are coupled to the respective surfaces of the pair of wings ofthe butterfly needle inserted into the patient access site.

In embodiments, a securing device for a butterfly needle can include awedge-shaped securing device and a bandage. The butterfly needle canhave a tip, a hub with a pair of wings extending radially therefrom, andtubing extending from the hub and in fluid communication with the tip.The wedge-shaped securing device can have a first surface arranged so asto be adjacent to skin of a patient and a second surface inclined withrespect to the first surface. The second surface can be arranged tocontact a back surface of said pair of wings. The bandage can have apair of flexible strips. Each strip can have an adhesive first portion,an adhesive second portion, and a middle portion between the first andsecond portions. The middle portion can be in contact with the firstsurface of the securing device such that the middle portion is betweenthe first surface and the patient skin. The second portion can adhere tothe second surface of the securing device. The first portion can bearranged so as to contact and adhere to the patient skin adjacent apatient access when the butterfly needle is inserted into the patientaccess and the second surface is in contact with the back surface of thepair of wings.

In embodiments, a method for connecting to a patient access site with abutterfly needle can include affixing the second region of a bandage tothe front surface of the pair of wings of the butterfly needle. Thebutterfly needle can include a tip, a hub with a pair of wings extendingradially therefrom, and tubing extending from the hub and in fluidcommunication with the tip. The bandage can be a pair of strips offlexible material. Each strip can have a first region, a second region,and a third region. The first region can have an adhesive on at least asurface portion thereof. The second region can also have an adhesive onat least a surface portion thereof. The second region can be affixed tothe front surface of the one of the pair of wings of the butterflyneedle. The third region can be arranged between the first and secondregions and to contact a back surface of one of the pair of wings of thebutterfly needle. The first region can be arranged so as to contact skinadjacent the patient access site when the second and third regions arecoupled to the respective surfaces of the pair of wings of the butterflyneedle inserted into the patient access site. The method can furtherinclude inserting the tip of the butterfly needle into the patientaccess site and affixing the first region of the each of the pair ofstrips onto skin of the patient adjacent the patient access site suchthat the third region of each strip contacts the respective back surfaceof the pair of wings.

In embodiments, a bandage can have a flexible material including a firstregion and a second region. The first region can have a first adhesivethereon and a viewing window portion without any adhesive. The viewingwindow portion can be configured such that a patient access site inwhich a needle is inserted is viewable through said window portion whenthe bandage is attached to the patient's skin. The second region canhave a second adhesive thereon and a hole therein. The second region canbe separated into a pair of longitudinally extending tabs by a cutextending from an end of the bandage to the hole. The hole can beconstructed such that a part of the needle fits in said hole when thebandage is attached to the patient's skin.

In embodiments, a method for using a bandage can include positioning aviewing window of a bandage over a patient access site, which has aneedle inserted therein. The method can further include adhering a firstadhesive in a first region of the bandage to the patient's skin. Tabs ina second region of the bandage can be separated and tubing attached tothe needle can be passed through a hole in the second region. The methodcan also include adhering a second adhesive of the tabs to the patient'sskin.

Objects and advantages of embodiments of the present disclosure willbecome apparent from the following description when considered inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

Embodiments will hereinafter be described in detail below with referenceto the accompanying drawings, wherein like reference numerals representlike elements. The accompanying drawings have not necessarily been drawnto scale. Where applicable, some features may not be illustrated toassist in the description of underlying features.

FIG. 1 shows a butterfly needle to which a bandage may be applied toprevent removal of the needle from a patient access.

FIGS. 2A-2B show a front view and a side view, respectively, of abandage for preventing removal of a needle from a patient access,according to one or more embodiments of the disclosed subject matter.

FIGS. 3A-3B show a front view and a side view, respectively, of thebandage of FIGS. 2A-2B in a first step of an application process to thebutterfly needle of FIG. 1.

FIGS. 3C-3D show a front view and a side view, respectively, of thebandage of FIGS. 2A-2B in a second step of an application process to thebutterfly needle of FIG. 1.

FIGS. 3E-3F show a front view and a side view, respectively, of thebandage of FIGS. 2A-2B in a third step of an application process to thebutterfly needle of FIG. 1.

FIGS. 3G-3H show a front view and a side view, respectively, of thebandage of FIGS. 2A-2B in a fourth step of an application process to thebutterfly needle of FIG. 1.

FIG. 3I shows a kit including a bandage assembled to a butterfly needle,according to one or more embodiments of the disclosed subject matter.

FIG. 3J shows an alternative kit including a bandage separate from abutterfly needle, according to one or more embodiments of the disclosedsubject matter.

FIGS. 4-6 show various steps in the operation of the assembled bandageand butterfly needle of FIGS. 3G-3H during insertion and removal from apatient access, according to one or more embodiments of the disclosedsubject matter.

FIGS. 7A-7B show a front view and a side view, respectively, of abandage with hemostasis pad cover, according to one or more embodimentsof the disclosed subject matter.

FIGS. 8A-8B show a front view and a side view, respectively, of thebandage of FIGS. 7A-7B applied to the butterfly needle of FIG. 1.

FIGS. 9-10 show various steps in the operation of the assembled bandageand butterfly needle of FIGS. 8A-8B during insertion and removal from apatient access, according to one or more embodiments of the disclosedsubject matter.

FIG. 11 shows a removal step of an assembled bandage and butterflyneedle with needle guard, according to one or more embodiments of thedisclosed subject matter.

FIGS. 12A-12B show a front view and a side view, respectively, of abandage with access site viewing window, according to one or moreembodiments of the disclosed subject matter.

FIGS. 13A-13B show a front view and a side view, respectively, of thebandage of FIGS. 12A-12B applied to the butterfly needle of FIG. 1.

FIG. 14 shows a needle guard that can be used with a bandage, accordingto one or more embodiments of the disclosed subject matter.

FIGS. 15-16 shows of a perspective view and a top view, respectively, ofthe assembled bandage and butterfly needle of FIG. 13A-13B together withthe needle guard of FIG. 14.

FIGS. 17-24 show various steps in the operation of the assembledbandage, butterfly needle, and needle guard of FIGS. 15-16 duringinsertion and removal from a patient access, according to one or moreembodiments of the disclosed subject matter.

FIGS. 25-26 shows a side view and a top view, respectively, of analternative bandage with hemostasis pad in use, according to one or moreembodiments of the disclosed subject matter.

FIGS. 27A-27B show a front view and side view, respectively, of abandage for preventing removal of a needle from a patient access,according to one or more embodiments of the disclosed subject matter.

FIG. 28 shows a bandage applied to a butterfly needle together with aneedle guard, according to one or more embodiments of the disclosedsubject matter.

FIGS. 29A-29B show a front view and a side view, respectively, of thebandage of FIGS. 27A-27B applied to the butterfly needle of FIG. 1

FIG. 30 shows a side view of the butterfly needle inserted into apatient access with the bandage of FIGS. 27A-27B applied to thebutterfly needle and securing the needle to the access.

FIGS. 31-34 show various steps in the securing of the bandage of FIGS.27A-27B to the patient skin after insertion of the butterfly needle.

FIG. 35 shows a needle securing device together with a butterfly needle,according to one or more embodiments of the disclosed subject matter.

FIG. 36 shows a side view of the butterfly needle inserted into apatient access with the bandage of FIGS. 27A-27B applied to the needlesecuring device of FIG. 35.

FIGS. 37-40 show various steps in the securing of the bandage of FIGS.27A-27B with the needle securing device to the patient skin afterinsertion of the butterfly needle.

FIG. 41 shows a bandage having a viewing window, according to one ormore embodiments of the disclosed subject matter.

FIG. 42 shows another bandage having a viewing window, according to oneor more embodiments of the disclosed subject matter.

FIG. 43 shows a pair of bandages packaged together, according to one ormore embodiments of the disclosed subject matter.

FIG. 44 shows the bandage of FIG. 41 applied to a butterfly needleinserted into a patient access, according to one or more embodiments ofthe disclosed subject matter.

FIG. 45 shows another bandage having a viewing window with a target,according to one or more embodiments of the disclosed subject matter.

FIG. 46 shows an aspect of one-handed application of the bandage of FIG.45, according to one or more embodiments of the disclosed subjectmatter.

FIG. 47 shows the bandage of FIG. 45 applied to a butterfly needleinserted into a patient access during a first step of a needle removalprocess, according to one or more embodiments of the disclosed subjectmatter.

FIG. 48 shows a top view of the bandage of FIG. 45 applied to abutterfly needle inserted into a patient access during a second step ofa needle removal process, according to one or more embodiments of thedisclosed subject matter.

FIG. 49 shows a top view of the bandage of FIG. 45 applied to abutterfly needle inserted into a patient access during a third step of aneedle removal process, according to one or more embodiments of thedisclosed subject matter.

DETAILED DESCRIPTION

Butterfly needles can be used for transfusions, in particular for takinga blood sample, or for providing a treatment to a patient, such as adialysis treatment. Such needles are termed butterfly needles on accountof a pair of wings that extend radially from a hub of the needle. FIG. 1shows an example of a butterfly needle 100. The needle 100 includes atip 106 for piercing the skin of a patient and for providing fluidcommunication between an opening on the tip 106 and tubing 108. Tubing108 can connect to other tubing, machines, or fluid receptacles, such asa blood sample vacuum tube. Tubing 108 is connected to the tip 106 by ahub 104. Hub 104 has a pair of wings 102 which extend radially from thehub.

By pressing the wings 102 together, handling of the needle 100 forinsertion into an access site of the patient is facilitated. When theneedle is inserted into a blood vessel or fistula, movement of theneedle within the patient can lead to complications, such as phlebitisor hematoma. Moreover, inadvertent or unintentional removal of theneedle from the patient access site can lead to blood loss from thepatient or loss of medicament or fluids that were in the process ofbeing administered to the patient. Accordingly, it is desirable toprevent movement of the butterfly needle once inserted into the patientaccess site.

A bandage 200 of flexible material can resist extraction and/or movementof the butterfly needle after insertion into the patient access site.Referring to FIGS. 2A-2B, bandage 200 can be made from a thin, flexiblematerial, such as a polymer. For example, the bandage can be made fromnylon fibers embedded in medical cloth. In another example, the bandageis made from a clear or transparent plastic material, such as apolyethylene film. Other materials may also be employed in accordancewith one or more contemplated embodiments.

The bandage 200 can be separated into multiple regions by three foldlines. However, it should be appreciated that fewer or additional foldlines and/or regions can be used. A top end region 204 is demarcated bya first fold line 208. An adhesive 206 is provided on the top end region204. The top end region 204 is arranged to be in contact with the skinof the patient when applied to a needle inserted into the patient. Thetop end region 204 also includes a portion 202 that is free fromadhesive. The portion 202 can be used to remove the bandage 200 from theskin of the patient after use. Between the first fold line 208 and asecond fold line 212 is an intermediate region 210. When the bandage 200is applied to the needle 100, the intermediate region 210 is arranged soas to contact a front side of the wings 102 of the needle 100. However,since there is no adhesive applied to the intermediate region 210, thebandage does not adhere to the front side of the wings 102. Between thesecond fold line 212 and the third fold line 218 is a wing contactregion 214. Wing contact region 214 has an adhesive 216 covering atleast a portion of said region 214. The adhesive 216 is designed toreleasably couple the bandage to wings 102 of the needle 100. When thebandage 200 is applied to the needle 100, the wing contact region 210 isarranged so as to contact a back side of the wings 102 of the needle100. The adhesive 216 thereby couples the bandage 200 to the needle 100for use on a patient. A bottom end portion is demarcated by the thirdfold line 218. The bottom end portion includes a pair of tabs 222separated by a gap 220. Gap 220 may also extend into the wing contactregion 214 so as to allow the tubing 108 to fit therethrough such thatthe wing contact region 214 can contact the entire back-side of thewings 102. The tabs 222 can be provided without any adhesive.

The top end region 204 can also include a clot promoting region, such ashemostasis pad 224. The hemostasis pad 224 can include, for example, agel or gauze with clot promoting material thereon. Since the top endregion 204 is arranged to be in contact with the skin of the patient,the hemostasis pad 224 can be positioned so as to contact the accesssite through which the needle 100 is inserted into the patient. When theneedle 100 is removed from the patient access site, the hemostasis pad224 contacts blood flowing from the access site to promote clotting(i.e., hemostasis).

Bandage 200 can be packaged separately from needle 100 and thenassembled to the needle 100 prior to use. One or more covers can beprovided on the areas of the bandage (for example, removably attached tothe various adhesive regions of the bandage) to prevent inadvertentcontact with a surface or the collection of dirt or other foreignobjects thereon. Even when the bandage 200 is previously assembled tothe needle 100, a cover may be provided to the regions of the bandage200 intended for contact with a patient's skin. Covers for the bandagecan be made from, for example, paper or a flexible polymer. For example,wing contact portion 214 can have a cover 228, which protects adhesive216. Prior to assembly of the bandage 200 to the wings 102 of the needle100, the cover 228 can be removed so as to expose adhesive 216. Inaddition, top end region 204 can have a cover 226, which protectsadhesive 206 and hemostasis pad 224 in said region. Prior to applicationof the bandage 200 to the patient's skin, the cover 226 can be removedso as to expose the adhesive 206.

FIGS. 3A-3H show steps in an assembly of the bandage 200 to the needle100. Referring to FIGS. 3A-3B, front and side views are shown of thewing contact region 214 contacting the back-side of wings 102. Theadhesive 216 of the wing contact region 214 releasably attaches thebandage to the needle 100. In FIGS. 3C-3D, the bandage 200 is foldedalong third fold line 218 such that tabs 222 are arranged behind thewings 102. In FIGS. 3E-3F, the top end region 204 and the intermediateregion 210 are folded down along second fold line 212. In FIGS. 3G-3H,the top end region 204 is then folded up along first fold line 208,resulting in a final assembled configuration.

Because of this configuration, cover 226 (not shown in FIGS. 3A-3H) canbe maintained on the top end region 204 even when the bandage has beenpreviously assembled to the needle 100. The cover 226 can be removedbefore or after insertion of the needle 100 into the patient accesssite. Moreover, the configuration can allow the top end region 204 to beapplied to the skin after insertion of the needle by simply unfoldingthe bandage along first fold line 208 and placing the top region 204into contact with the skin. The configuration can also allow positioningof the hemostasis pad 224 with respect to the patient access site.

The needle 100 and the bandage 200 in the assembled configuration ofFIGS. 3G-3H can be provided as part of a kit. Referring to FIG. 3I, akit 300A for venipuncture can include a needle and bandage assembly thathave been previously coupled together and sterilized in a bag 310 orother container. The tip 106 of the needle 100 can be protected by a cap302 to prevent against inadvertent contact. Tubing 108 of the needle canbe connected to an additional length of tubing 308. Alternatively,tubing 108 and tubing 308 can be combined into a single length oftubing. A clamp 304 can be provided on tubing 308 in order to stop theflow of fluids flowing through the tubing 308 and the needle 100. Aconnector 306 can also be provided for connecting the tubing 308 to afluid receptacle, such as a blood sample container, or a treatmentmachine, such as a dialysis system. Cover 226 protects adhesive 206 ofthe top end region 204 of the bandage 200 prior to actual use. In analternative configuration, a kit 300B for venipuncture can include theneedle 100 and bandage 200 in an unassembled configuration, as shown inFIG. 3J. Prior to use, the cover 228 of the wing contact region 214 isremoved to allow the bandage 200 to be applied to the needle 100, asshown in FIGS. 3A-3H.

When attached to the needle 100, the arrangement of the top end region204 and the wing contact region 214 of the bandage 200 is such that theneedle 100 is prevented from moving away from the patient access site.Referring to FIG. 4, a needle-bandage assembly used in accessing afistula 402 is shown. The wing contact region 214 of the bandage 200 isattached to the back-side of the wings 102 prior to inserting the needle100 into the patient. The tip 106 of the needle 100 can be inserted intothe patient by piercing the skin 404 through an access site 406. Thebandage 200 loops over the front-side of the wings 102 such that theintermediate region 210 may be in contact with at least a portion of thefront-side of the wings 102. The top end region 204 can be attached tothe skin 404 of the patient and can hold the needle-bandage assembly inplace with the needle 100 inserted into the patient access site 406.

When it is desired to remove the needle 100 from the patient, thebandage can be released from the needle 100. Referring to FIG. 5, thewing contact region 214 can be released from the wings 102 by pulling ontabs 222. This action peels the bandage from the wings 102 while theneedle 100 remains in place. Once the wing contact region 214 of thebandage 200 is removed from the butterfly needle 100, the needle 100 canbe freely withdrawn from the access site while the bandage 200 remainsin contact with the patient's skin, as shown in FIG. 6.

As blood is likely to exit through the patient access site 406 when itis vacated by the needle, a user may apply finger pressure 408 tocontact the hemostasis pad 224 with the patient access site 406 as theneedle 100 is removed to promote clotting at the access site. Once theneedle 100 is fully removed, finger pressure 408 may be maintained tocontact the hemostasis pad 224 with the access site 406 until bleedinghas stopped. Alternatively, once the needle 100 is fully removed,alternative means of applying continued pressure against the hemostasispad 224 and the access site 406 may be used. For example, an additionalbandage or tape may be applied to maintain pressure against thehemostasis pad 224 to promote hemostasis. The bandage 200 can be furthersecured to the skin 404 by the wing contact region 214 in addition tothe top end region 204 so as to keep the hemostasis pad 224 in placeover the patient access site 406. In another example, an air-filledbubble can be taped over the bandage 200 such that the bubble continuesto apply pressure to the access site 406 through the bandage 200.

Since the hemostasis pad 224 is not in use until the needle 100 isactually removed from the patient access site 406, a separate cover canbe provided for the hemostasis pad. Referring to FIGS. 7A-7B, a bandage200 with a hemostasis pad cover 700 is shown. The hemostasis pad cover700 can include a covering portion 702 which protects the hemostasis pad224 prior to removal of needle 100 from the patient access site. Thehemostasis pad cover 700 can also include a portion that attaches to theneedle. For example, the hemostasis pad cover 700 can include a wingedportion 704 that can wrap around the tubing 108 or a portion of the hub104 of the needle 100. Alternatively or additionally, portion 704 caninclude adhesive to couple the hemostasis pad cover 700 to the needle.The bandage 200 with a hemostasis pad cover 700 assembled to a needle100 is shown in FIGS. 8A-8B.

FIG. 9 shows the bandage 200 with hemostasis pad cover 700 assembled toa needle 100, which is inserted into a patient access site 406. Coveringportion 702 of the hemostasis pad cover 702 can remain in place toprotect the hemostasis pad 224 until needle extraction from the accesssite 406. Winged portion 704 can be wrapped around the circumference ofthe tubing, thereby coupling the hemostasis pad cover 700 to the needle100. Referring to FIG. 10, as the needle 100 is removed from the patientaccess site 406 while keeping bandage 200 in place, the covering portion702 can be simultaneously removed from the hemostasis pad 224, therebyexposing the hemostasis pad 224 to the patient access site 406.

Because of the danger of disease transmission and/or risk of injury tothose handling used needles (such as medical staff or medical wastehandlers), safety devices can be employed to avoid accidental touchingor pricking of the handlers by the used needle. For example, a needleguard 1100 may be used to contain the needle after use. Referring toFIG. 11, bandage 200 is shown in use with such a needle guard 1100.Needle guard 1100 can be movably coupled to the tubing, which extendsthrough an opening at a rear portion of guard 1100. During insertion anduse of the needle, the needle guard 1100 can be maintained at a positionalong the tubing 108 remote from the patient access site 406. When it isdesired to remove the needle 100, the wing contact region 214 of bandage200 can be released from the wings 102 of the needle 100, and the needleguard 1100 can be moved into place proximal to the patient access site406.

The needle guard can include a front opening 1104 through which theneedle 100 and tubing 108 can pass. A locking region 1106 can beprovided at the rear of the needle guard 1100. As the needle 100 isremoved from the access site 406, it progresses into the opening 1104and into the body of the needle guard 1100. At the rear of the needleguard 1100, the wings 102 of the needle can be captured by the lockingregion 1106, thereby preventing further motion of the needle 100 into orout of the needle guard 1100. The needle guard 1100 can be sized andshaped such that the tip 106 of the needle is fully contained within thebody of the needle guard 1100 when the wings 102 of the needle 100 arecaptured by the locking region 1106, thereby preventing inadvertentcontact with needle tip 106. Needle guard 1100 may further include afinger guard 1102. The finger guard 1102 can be sized and shaped so asto allow finger pressure 408 to be applied to the hemostasis pad 224 andthe access site 406 underneath when the needle guard 1100 is inposition. The finger guard 1102 may be detachable such that fingerpressure 408 may continue to be applied even when the needle guard 1100with needle 100 therein is removed for disposal.

A bandage for securing the butterfly needle can include a viewing windowthat is arranged over the patient access site in order to provide a viewthereof. For example, bandage 1200, as shown in FIGS. 12A-12B, has aviewing window 1224. Bandage 1200 can be made from a thin, flexiblematerial, such as a polymer. For example, the bandage can be made from aclear or substantially transparent plastic material, such as apolyethylene film. Other materials may also be employed in accordancewith one or more contemplated embodiments.

The bandage 1200 can be separated into multiple regions by one or morefold lines. However, it should be appreciated that fewer or additionalfold lines and regions can be used. As shown in FIGS. 12A-12B, a top endregion 1204 can be demarcated by a first fold line 1208. An adhesive1206 can be provided on the top end region 1204. The top end region 1204can be arranged for contact with the skin of the patient when applied toa needle inserted into the patient. The top end region 1204 can alsoinclude an optional portion 1202 that is free from adhesive. The portion1202 can then be used to remove the bandage 1200 from the skin of thepatient after use. The top end region 1204 can also include a viewingwindow region, such as window 1224. This window 1224 may be anadhesive-free region and can be substantially transparent to allow arelatively unobstructed view of the scene on the opposite side of thewindow 1224. Since the top end region 1204 is arranged to be in contactwith the skin of the patient, the window 1224 is positioned over theaccess site through which the needle 100 is inserted into the patient.The window 1224 thus allows medical personnel or a patient to view theaccess site, for example, to monitor for complications.

Between the first fold line 1208 and a second fold line 1218 is a wingcontact region 1214. Wing contact region 1214 can have an adhesive 1216covering at least a portion thereof. The adhesive 1216 can be designedto releasably attach the bandage to wings 102 of the needle 100. Whenthe bandage 1200 is applied to the needle 100, the wing contact region1210 is arranged so as to contact a back side of the wings 102 of theneedle 100. The adhesive 1216 thereby couples the bandage 1200 to theneedle 100 for use on a patient. A bottom end portion can be demarcatedby the second fold line 1218. The bottom end portion can include a pairof tabs 1222 separated by a gap 1220. Gap 1220 may also extend into thetop end region 1204 and wing contact region 1214. The tabs 1222 can beprovided without any adhesive.

As discussed herein, one or more covers can be provided on the bandageto prevent inadvertent contact with a surface or the collection of dirtor other foreign objects. Even when the bandage 1200 is assembled to theneedle 100 prior to use, one or more covers can be provided to thatregion of the bandage 1200 meant for contact with a patient's skin. Suchcovers can be made from, for example, paper or a flexible polymer. Forexample, wing contact portion 1214 may have a cover 1228, which protectsthe adhesive 1216. Prior to assembly of the bandage 1200 to the wings102 of the needle 100, the cover 1228 can be removed, thereby exposingthe adhesive 1216. In addition, top end region 1204 can have a cover1226, which protects a top part of the adhesive 1206 in said region.Prior to application of the bandage 1200 to the patient's skin, thecover 1226 can be removed, thereby exposing the top portion of adhesive1206. The bottom portion of the adhesive 1206 can have a separate cover1230. The bottom portion of the adhesive 1206 can be exposed afterremoval of the needle 102 to adhere the remainder of the top end region1204 to the skin, thereby surrounding the patient access site. Thebandage 1200 assembled to a needle 100 is shown in FIGS. 13A-13B.

Referring to FIGS. 14-16, an assembly with a needle guard 1400 and abandage 1200 for a butterfly needle 100 is shown. Needle guard 1400 canbe movably coupled to the tubing 1410, which extends through an openingat a rear 1408 thereof. During insertion and use of the needle, theneedle guard 1400 can be maintained at a position along the tubing 1410remote from the patient access site. When it is desired to remove theneedle 100, the wing contact region 1214 of bandage 1200 can be releasedfrom the wings 102 of the needle 100, and the needle guard 1400 can bemoved into place proximal to the patient access site.

The needle guard can include a front opening 1404 through which theneedle 100 and tubing 1410 can pass. A locking region 1406 can beprovided at the rear of the needle guard 1400. As the needle 100 isremoved from the access site, it can progress into the opening 1404 andinto the body of the needle guard 1400. At the rear of the needle guard1400, the wings 102 of the needle can be captured by the locking region1406, thereby preventing further motion of the needle 100 into or out ofthe needle guard 1400. The needle guard 1400 can be appropriately sizedand shaped such that the tip 106 of the needle is fully contained withinthe body of the needle guard 1400 when the wings 102 of the needle 100are captured by the locking region 1406, thereby preventing inadvertentcontact with said tip 106.

Needle guard 1400 may further include a bowl-shaped finger guard 1402.The finger guard 1402 can be sized and shaped so as to allow fingerpressure to be applied to the access site when the needle guard 1400 isin position. The finger guard 1402 can be detachable such that fingerpressure can be continuously applied even when the needle guard 1400with needle 100 therein is removed for disposal. For example, fingerguard 1402 can be attached to the top surface 1414 of the needle guard1400 by a piece of tape 1412. Alternatively, finger guard 1402 can beattached to the needle guard 1400 by a frangible or break-away portionof the needle guard 1400.

When attached to the needle 100 and the patient, the arrangement of thetop end region 1204 and the wing contact region 1214 of the bandage 1200prevents the needle 100 from moving away from the patient access site406. The wing contact region 1214 of the bandage 1200 can be attached tothe back-side of the wings 102. The needle 100 can then be inserted intothe patient access site 406, as shown in FIG. 17. Cover 1226 can beremoved thereby exposing the top portion of adhesive 1206 in top endregion 1204, as shown in FIG. 18. Cover 1230 can remain in place untilthe needle 100 is removed from the patient access site 406. The top endregion 1204 can be looped over the front-side of the wings 102 byfolding along fold line 1208. Cover 1230 can thus be in contact with atleast a portion of the front-side of the wings 102. The top end region1204 can be attached to the skin of the patient so as to hold theneedle-bandage assembly in place while the needle 100 inserted into thepatient access site 406, as shown in FIG. 19. Window 1224 can bepositioned over patient access site 406 to allow medical personnel orthe patient to view the needle in the access site.

When it is desired to remove the needle 100 from the patient, thebandage 1200 can be released from the needle 100. The wing contactregion 1214 may be released from the wings 102 by pulling on tabs 1222,as shown in FIG. 20. This action peels the bandage from the wings 102while the needle 100 remains in place in the patient access. Oncedisconnected from the bandage, in particular, region 1204, the needle100 can be removed while the bandage 1200 remains in contact with thepatient's skin. The needle guard 1400 can be moved into positionproximal to the patient access site 406 prior to removing the needle100, as shown in FIG. 21. Finger pressure can be applied to the patientaccess site 406 by pushing on finger guard 1402. Needle 100 can then beremoved by pulling on tubing 1410 until the needle is retracted into theneedle guard, as shown in FIG. 22. The finger guard 1402 can be detachedfrom the needle guard 1400 by removing tape 1412. The needle guard 1400with needle 100 therein can be moved from the patient access site whilepressure is maintained on the patient access site 406, as shown in FIG.23. The bandage 1200 can be fully applied to the skin by removing cover1230 from the remainder of the top end region 1204. A tab 1230 a (seeFIG. 19) can be provided to easily remove the cover 1230 from thebandage 1200, after which all of the top end region 1204 can be affixedto the skin of the patient so as to surround the patient access site406, as shown in FIG. 24.

Concepts and features of the disclosed embodiments can be applied toother configurations of bandages for securing needles and/or promotinghemostasis. For example, the disclosed hemostasis pad may be combinedwith other types of securing bandages to promote hemostasis afterremoval of the needle. Referring to FIGS. 25-26, an embodiment of abandage for securing a needle 100 to a patient access site is shown. Thebandage has a skin-contact portion 2500 with a hemostasis pad 2524arranged so as to contact the patient access site 406, through which thetip 106 of needle 102 is inserted. The skin-contact portion 2500 ispositioned under the wings 102 of the needle. To hold the wings 102 ofthe needle 100 against the skin, a separate piece of tape or bandage2520 is provided. The tape 2520 extends over the top surface of thewings 102 of the needle and exerts a force on the wings 102 holding thewings against the skin of the patient. The bandage also includes two tabregions 2522 with adhesive on an end thereof. The tab regions 2522 looparound the back-side of the wings and are adhered to the skin proximalto skin-contact region 2500. This configuration of the tab regions 2522looped around the wings 102 thus prevents inadvertent withdrawal of theneedle from the patient access site 406. When it is desired to removethe needle 100, the tab regions 2522 can be peeled from the skin, andthe tape 2520 can subsequently be removed. The needle 100 can thus beremoved from the patient access site while the skin-contact portion 2500remains in place. The hemostasis pad 2524 is in contact with the patientaccess site 406 as the needle is removed therefrom.

In another embodiment, the needle can be secured using a bandage that isattached to the needle wings and looping the bandage over the wings toattach to the skin. For example, two strips of medical tap can be usedto secure the needle using a looping arrangement with respect to theneedle wings. Such strips 2200A, 2200B are shown in FIGS. 27A-27B. Eachstrip 2200A, 2200B can be made from a thin, flexible material, such as apolymer. Each bandage strip 2200A, 2200B can be separated into multipleregions by two fold lines. However, it should be appreciated that feweror additional fold lines and/or regions can be used. A top end region2204 is demarcated by a first fold line 2208. An adhesive 2206 isprovide in at least the top end region 2204, but can also extend to theother regions of the strip 2200 as shown. Alternatively, one or more ofthe regions 2204, 2210, and 2214 may be provided with a differentadhesive or no adhesive at all in accordance with the teachings of thepresent disclosure. In addition, certain adhesives may be employed wherecontact with patient's skin is likely so as to avoid potential patientallergic reactions while other regions may employ different adhesives.The top end region 2204 can be arranged to be in contact with the skinof the patient when applied to a needle inserted into the patient. Thetop end region 2204 can also include a portion 2202 that is free fromadhesive. The portion 2202 can then be used to remove the strip 2200from the skin of the patient after use.

Between the first fold line 2208 and a second fold line 2212 is anintermediate region 2210. When the bandage 2200 is applied to the needle100, the intermediate region 2210 is arranged so as to contact aback-side of the wings 102 of the needles, as shown in FIG. 29B.Adhesive may be applied to the intermediate region 2210. Optionally,adhesive in region 2210 may be omitted. Between the second fold line2212 and the other end of strip 2200 is a wing contact region 2214. Wingcontact region 2214 can have an adhesive covering at least a portion ofsaid region 2214. The adhesive in region 2214 can be the same adhesive2206 as in region 2204. Alternatively, the adhesive in region 2214 canbe different from the adhesive in region 2204. The adhesive in region2214 can be designed to attach the bandage to wings 104 of the needle100. When the strip 2200 is applied to the needle 100, the wing contactregion 2214 is arranged so as to contact a front-side of the wings 102of the needle 100, as shown in FIGS. 29A-29B. The adhesive 2206 inregion 2214 thereby couples the strip 2200 to the needle 100 for use.

Strips 2200 can be packaged separately from needle 100 and thenassembled to the needle 100 prior to use. One or more covers can beprovided for the strips to prevent inadvertent contact with a surface orthe collection of dirt or other foreign objects. When the strips 2200are assembled to the needle 100 prior to use, a cover can remain on theregion of the strips 2200 meant for contact with the patient's skin.Such covers may be made from, for example, paper or a flexible polymer.For example, wing contact region 2214 and intermediate region 2210 canhave a cover 2228 which protects the adhesive 2206 in those regions.Prior to assembly of the strips 2200 to the wings of the needle 100, thecover 2228 can be removed, thereby exposing the adhesive in regions 2214and 2210. Region 2214 can then be adhered to the front-side of one ofthe wings while region 2210 of strip 2200 can be adhered to theback-side of one of the wings, with region 2204 extending away from thetip 106 of needle 100, as shown in FIGS. 28-29B. Top end region 2204 canhave an additional cover 2224, which protects the adhesive 2206 in saidregion. Prior to application of the strip 2200 to the patient's skin,the cover 2224 can be removed, thereby exposing the adhesive 2206 in thetop end region 2204.

When attached to the needle 100, the arrangement of the top end region2204 and the wing contact region 2214 of each strip 2200 can preventneedle 100 from moving away from the patient access site. Referring toFIG. 30, a needle-bandage assembly using the bandage strips of FIGS.27A-27B is shown. At least the wing contact region 2214 of each strip2200 can be attached to the front-side of the wings 102 prior toinsertion of the needle 100 into the patient. The intermediate region2210 can also be attached to the back-side of the wings 102 prior toinsertion of the needle 100. The tip 106 of the needle 100 can beinserted into the patient by piercing the skin 402 to connect to anaccess site 406, as shown in FIG. 31. As shown in FIG. 32, the cover2224 can be removed from the top end region 2204 before attaching thetop end region to the patient skin. Referring to FIGS. 32-33, each strip2200 loops behind the wings and then over the front-side of the wings102 with the intermediate region 2210 in contact with at least a portionof the back-side of the wings 102. The top end region 2204 of each strip2200 is attached to the skin 402 of the patient and holds theneedle-bandage assembly in place with the needle 100 inserted into thepatient access site 406, as shown in FIG. 34.

FIG. 35 shows a needle securing device 3500 with needle 100. Securingdevice 2500 can include separate wedge-shaped portions 3502 heldtogether by a strap 3504, through which the tube 108 of needle 100passes. A bottom surface of the wedge-shaped portion can be designed tosit on top of the patient's skin. A first top surface region of thewedge-shaped portion can be inclined or angled with respect to thebottom surface so as to contact the wings 102 of the needle, therebyabutting the ends of the wings 102 and preventing withdrawal of theneedle from the patient access site. To secure the securing device inplace against the patient skin, tape can be applied against to a secondtop surface region of the wedge-shaped portion.

The bandage configuration of FIGS. 27A-27B can also be applied to thesecuring device-needle assembly to secure the assembly to a patientaccess site. As shown in FIG. 36, wing contact region 2214 can beadhered to the first top surface region of the wedge-shaped portion3502. The strip 2200 can then be looped around the securing device 3502and the wings 102 of the needle. Intermediate region 2210 can be incontact with the bottom surface of the wedge-shaped portion 3502,between the bottom surface and the patient's skin. The top end portion2204 can be arranged over the front-side of the wings 102 and can beadhered to the surface of the skin adjacent to the patient access siteas shown. When attached to the needle 100 and the securing device 3502,the arrangement of the top end region 2204 and the wing contact region2214 of each strip 2200 prevents needle 100 from withdrawing from thepatient access site. Moreover, since the securing device 3500 isseparate from the needle 100, the bandage strips 2200 can be attached tothe securing device 3500 before being applied to a needle inserted intothe access. After insertion of the needle 100 into a patient accesssite, the securing device 3502 can be put into place and secured usingthe bandage strips 2200.

At least the wing contact region 2214 of each strip 2200 can be attachedto the first top surface region of the wedge-shaped portion 3502. Theintermediate region 2210 may also be attached to the bottom surface ofthe wedge-shaped portion 3502. After insertion of the needle 100 intothe access site, the wedge-shaped portion 3502 with pre-assembled strips2200 can be moved into place adjacent the wings 102 of the needle, asshown in FIG. 38. Referring to FIGS. 39-40, each strip 2200 can looparound the wedge-shaped portion and over the front-side of the wings 102with the intermediate region 2210 in contact with the bottom surface ofthe wedge-shaped portion 3502. The top end region 2204 of each strip2200 can be attached to the skin 402 of the patient and can hold theneedle-securing device assembly in place with the needle 100 insertedinto the patient access site 406, as shown in FIG. 40.

Referring to FIG. 41, a bandage 4100 for use in securing a needle to apatient access site and/or promoting clotting of the patient access siteafter needle removal is shown. The bandage 4100 can include a firstregion 4112 having a first adhesive thereon and a second region 4114having a second adhesive thereon. The first and second adhesives may bethe same. Both the first and second adhesive may be any adhesive that iscommonly used in bandage applications, such as Tegaderm™ (availablethrough 3M™). Within the first region 4112 can be a viewing window 4102.The viewing window 4102 can be sized and shaped to provide a view of theregion surrounding a needle insertion point. The window can have atapered shape as shown in FIG. 41, a circular or elliptical shape asshown in FIG. 42, or any other shape capable of providing a view of theneedle insertion point underneath the bandage. The viewing window (andeven the entire bandage) may be formed from a material that istransparent or at least substantially translucent so as to permitadequate inspection of the underlying needle insertion point. Theviewing window 4102 can be positioned such that a person can view thepatient access site with the needle therein when the bandage is placedover the patient access site. In particular, the viewing window 4102 canbe provided without an adhesive. After removal of the needle, fingerpressure can be applied to the viewing window 4102 and thereby to thepatient access site to encourage clotting.

The second region 4114 can include a hole 4102 that allows a portion ofthe needle body to pass therethrough. The hole 4102 can be arranged suchthat the second region 4114 is attached to only a portion of the needlehub when the needle is inserted into the patient access site and theviewing window 4102 of the first region 4112 is aligned with the patientaccess site. For example, a portion of the adhesive in the second region4114 may be disposed so as to adhere to only the rear half of wings of abutterfly needle (see, for example, FIG. 44). The second region 4114 canbe divided into two substantially equal size tabs 4104 by a cut lineextending longitudinally from the hole 4102 to an end of the bandage4100. In use, tabs 4104 can be positioned on the patient's skin so as tohave a gap therebetween (see, for example, FIG. 44). Alternatively, hole4102 can be extended to the end of the bandage 4100, thereby producing apair of tabs 4104 with a gap therebetween. The ends 4110 of the tabs4104 of the second region 4114 can be provided without any adhesive toassist in removal of the tabs 4104 from the patient skin aftertreatment.

The bandage 4100 can also be provided with one or more covers to protectthe surfaces of the bandage 4100 prior to use. Such covers can be formedfrom paper and/or a flexible polymer. The first region 4112 can have afirst cover, while each tab 4104 in the second region 4114 can have itsown respective cover. Although the covers are not specifically shown inFIG. 41, the first cover is represented by the respective edges of thebandage 4100 in the first region 4112 and a first demarcation line 4108.The respective covers for the tabs 4104 are also represented by therespective edges of the bandage in the second region 4114, the firstdemarcation line 4108, and a second demarcation line 4106. Demarcationlines 4106, 4108 can represent cut lines such that the individual coversfor the first and second regions can be formed from a single piece ofmaterial.

A third region 4118 can be provided between the first region 4112 andthe second region 4118. In some embodiments, the third region 4118 canbe provided without any adhesive thereon to assist in removal of thebandage 4100 from the needle and/or patient skin. In such aconfiguration, the third region 4118 can be protected by the one or morecovers protecting the first and second regions, as reflected by thecover demarcation lines 4106, 4108. In other embodiments, third region4118 can be provided with adhesive but with a cover separate from eitherthe first or second regions. This cover may be removed after needleremoval to expose the adhesive in the third region to assist in thehemostasis process.

The bandage 4100 can be made of a flexible material. For example, thebandage 4100 can be made of a clear polyethylene film. The polyethylenefilm can have a thickness of, for example, approximately 0.007 cm to0.038 cm. The bandage can be substantially rectangular with a widthbetween approximately 4 cm and 5 cm (e.g., 4.1 cm) and a length betweenapproximately 6.5 cm and 8 cm (e.g., 7.6 cm). Other sizes and shapes forthe bandage and the various features thereof are also possible accordingto one or more contemplated embodiments. In addition, the bandage mayinclude a component to assist in applying pressure to the access siteafter needle removal. For example, the viewing window may include abubble-shaped protrusion, such as an air-filled bubble portion, forapplying pressure to the access site. Alternatively, the bubble portioncan be provided separate from the bandage, for example, on a separatepiece of tape applied over the viewing window after needle removal toapply pressure to the bleeding access site.

Another embodiment of a bandage 4200 is shown in FIG. 42. Bandage 4200is similar to bandage 4100 in that it includes a viewing window 4202, afirst region 4212, a second region 4214, a hole 4202, tabs defined bycutline 4206, and a third region 4218. As with bandage 4100, demarcationlines 4204, 4208 can represent cut lines for forming individual coversfor each region of the bandage 4200. In contrast to bandage 4100,viewing window 4202 can be substantially circular. The adhesive in thefirst region 4212 can be arranged to follow a back edge of the viewingwindow 4202. In addition, the size of the third region 4218 is expandedas compared to that of bandage 4100. The expanded third region 4218 canbe arranged to coincide with a portion of the needle structure, e.g.,the front portion of wings of the needle. This may facilitate needleremoval since only a smaller portion of the wings of the needle areconnected to the bandage.

One or more of bandages 4200 (or any of the other bandages disclosedherein) can be fabricated from a single piece of rectangular material.For example, a pair of bandages can be formed from a single piece ofmaterial 4300, as shown in FIG. 43. The piece of material can be, forexample, between 4 cm and 5 cm in width and between 13 and 16 cm inlength. A first bandage 4302 can be formed from a first half of thematerial by applying adhesive and introducing cuts/holes at appropriateportions thereof. A second bandage 4304 can be similarly formed from thesecond half of the material 4300. A perforation can be introducedbetween the first bandage 4302 and the second bandage 4304 to allow auser to separate the first and second bandages prior to use. The firstand second bandages formed on the single piece of material can be partof a kit, for example, with a twin-pack of needles for use by a patient.

Referring to FIG. 44, a bandage 4400 is shown applied to a patientaccess site with a needle 4424 inserted therein. Bandage 4400 issubstantially similar to the bandage 4200 shown in FIG. 42. Viewingwindow 4402 of the first region 4412 can be arranged over the patientaccess site so as to allow inspection thereof while the needle 4424 isinserted into the site. Tubing 4418 extends rearward from a hub of theneedle through a hole in the second region 4414 of the bandage 4400. Thetabs of the second region 4414, defined by cut line 4406, can be adheredto the patient's skin and rear portions of the wings 4426 of the needle4424. The wings 4426 are thereby held against the patient's skinpreventing movement of the needle 4424 away from the patient accesssite. The third region, arranged between the first region 4412 and thesecond region 4414 of the bandage 4400, can be adhesive-less.

When treatment is complete, the second region 4414 can be peeled fromthe skin using tabs 4424. As the second region 4414 is pulled away fromthe skin, the adhesive of the bandage in the first and second regionscan also be pulled away from the wings 4426 of the needle 4424, therebyallowing the needle to be removed from the patient access site. At leasta portion of the first region 4412 can remain attached to the patient'sskin during needle removal such that the bandage remains aligned withthe patient access site. After needle removal, the adhesive regionsurrounding the viewing window 4402 in the first region 4412 can bepressed down to adhere to the patient's skin and form a barrier aroundthe access site. Finger pressure can be applied to access site throughthe viewing window 4402 during and/or after needle removal to encourageclotting.

Another embodiment of a bandage 4500 is shown in FIG. 45. Bandage 4500is similar to bandage 4200 of FIG. 42. In contrast to bandage 4200, theshape and position of the third region (between first region 4512 andtabs 4528 of the second region) is such that a smaller portion of theneedle wings are attached to the bandage 4500 to provide more convenientneedle removal. In addition, the viewing window can be provided with amarking or target 4502 to assist in the positioning of the viewingwindow over the patient access site. For example, the target 4502 can bearranged to account for potential misalignment due to a skewed viewingangle.

The bandages and needle systems disclosed herein have particularapplication to patients who may be self-cannulating, for example, toundergo home dialysis treatments. Accordingly, aspects of the disclosedbandages and needle systems may allow for single-handed operation suchthat a patient can insert a needle into an access on one arm using theopposite hand without assistance from someone else. Referring to FIG.46, a bandage 4600 can be held by a single hand 4632 for application tothe skin of a patient. The structure of bandage 4600 can besubstantially similar to that of bandage 4500 shown in FIG. 45. Thepatient may hold the bandage 4600 using thumb 4634, index finger 4640,and/or middle finger (not shown) so as to curl the bandage 4600 into aU-shape. The curling may allow for easy removal of cover 4638 of thefirst region by the other hand of the patient while cover 4642 of thesecond region remains in place.

The bandage 4600 can be applied using a single-hand 4632 by lightlydragging the first region over the skin until the viewing window 4625lines up with the needle entry of the patient access. Once the viewingwindow 4625 is aligned, the first region may be adhered to the skin bypressing down on the various parts of the first region using the middlefinger and thumb of hand 4632. The tabs 4614 of the second region can bepositioned by hand 4632 around the tubing 4618 connected to needle 4624such that the tubing 4618 passes through the hole of the second region.Hand 4632 can then remove the second cover 4642 to expose the adhesiveof the second region. The tabs 4614 of the second region can be appliedto the skin using hand 4632 to thereby secure the needle 4624 in placein the patient access. Note that the shape of the second and thirdregions can be such that only an outer edge portion 4634 of the needlewings 4626 are adhered to bandage 4600. The needle 4624 can thus beretained in place while allowing for easy one-handed removal of theneedle when treatment is finished.

To allow removal of the needle 4624 from the patient access site, thebandage can be manipulated by hand 4632. Referring to FIGS. 47-48, afirst step in the bandage manipulation for needle removal is shown. Inparticular, each of the tabs 4614 of the second region can be removedfrom the patient's skin and folded under along direction 4636 so as tostick to itself, resulting in angled tab portions 4716. In other words,each tab is folded along edge A, which is angled with respect to thelongitudinal axis of the tab such that edges B and C and parallel todirection 4736. The folded tab can thus be attached to itself withupturned adhesive portions 4615 remaining exposed. As shown in FIG. 48,the adhesive portion of the bandage can remain connected to the portionof the wings 4634.

Referring to FIG. 49, each tab can again be folded back on itself, thistime along direction 4840. In other words, each tab can be folded alongedge C such that the exposed portions 4615 are adhered to the topsurface of the bandage 4600. Wings 4826 are thus detached from adhesivein the second region of the bandage 4600. Hand 4632 can then removeneedle from the access site. For example, hand 4632 can press down onthe top surface of the folded tabs 4827 directly over the viewing windowusing the index finger while the thumb and the middle finger of hand4632 can be used to remove the needle from the access site.

To assist the patient and/or user in the manipulation of the bandage toallow needle removal, the tabs can include printed lines to indicatewhere the tab should be folded. In addition, the tabs can include atarget (not shown) corresponding to the location of the viewing windowwhen the tabs are in the folded configuration of FIG. 49. Thepatient/user can press on the labeled target to apply pressure to theneedle access even though the viewing window may be covered andotherwise obscured. After removing the needle, the thumb and middlefinger of hand 4632 can push down on the regions of the first regionsurrounding the viewing window into contact with the patient's skin. Theindex finger of hand 4632 can continue to apply pressure to the patientaccess site until hemostasis occurs. The bandage can be maintained onthe skin for a period of time to protect the wound after clotting. Whendesired, the bandage can be removed without affecting the scab of thewound since the viewing window in contact with the scab does not haveany gauze or cotton.

Features of the disclosed embodiments may be combined, rearranged,omitted, etc., within the scope of the present disclosure to produceadditional embodiments. Furthermore, certain features may sometimes beused to advantage without a corresponding use of other features.

It is, thus, apparent that there is provided, in accordance with thepresent disclosure, safe needle and bandage methods, apparatus, andsystems. Many alternatives, modifications, and variations are enabled bythe present disclosure. While specific embodiments have been shown anddescribed in detail to illustrate the application of the principles ofthe invention, it will be understood that the invention may be embodiedotherwise without departing from such principles. Accordingly,Applicants intend to embrace all such alternatives, modifications,equivalents, and variations that are within the spirit and scope of thepresent invention.

1. A bandage for securing a butterfly needle to a patient access site,the needle having a pair of wings extending radially from the hub of theneedle, the bandage comprising: a flexible material having: a firstregion with a first adhesive on at least a surface portion thereof; asecond region with a gap therein so as to form a pair of tabs separatedby said gap, the tabs being free from adhesive; and a third regionarranged between the first and second regions, the third region having asecond adhesive on at least a surface portion thereof; and a hemostasispad arranged in said first region, the hemostasis pad being constructedto promote clotting of blood that contacts said pad, wherein the thirdregion is arranged so as to contact the pair of wings of the butterflyneedle for releasably coupling the bandage thereto, and the hemostasispad is arranged so as to contact the patient access site when the thirdregion is coupled to the butterfly needle inserted into the patientaccess site.
 2. The bandage of claim 1, wherein the first region isarranged so as to releasably couple the bandage to the skin of thepatient when the third region is coupled to the butterfly needleinserted into the patient access site.
 3. The bandage of claim 1,wherein said second region tabs are free from adhesive.
 4. The bandageof claim 1, wherein the hemostasis pad includes a gel with clotpromoting material.
 5. The bandage of claim 1, wherein the hemostasispad includes gauze with clot promoting material.
 6. The bandage of claim1, wherein the first adhesive is configured for contact with and toadhere to a patient's skin.
 7. The bandage of claim 1, wherein thesecond adhesive is configured for contact with and to adhere to the pairof wings of the butterfly needle.
 8. The bandage of claim 1, whereinsaid flexible material is a plastic material.
 9. The bandage of claim 1,wherein said flexible material is a transparent material.
 10. Thebandage of claim 1, further comprising a hemostasis pad cover, whichincludes a portion that covers the hemostasis pad during insertion anduse of the butterfly needle.
 11. The bandage of claim 10, wherein thehemostasis pad cover includes a T-shaped portion for attaching the coverto tubing of the butterfly needle by wrapping around a circumferencethereof, and the hemostasis pad cover is arranged such that the portionthat covers the hemostasis pad is removed as the needle is removed fromthe patient access, thereby exposing the hemostasis pad to blood fromthe patient access.
 12. The bandage of claim 10, wherein the hemostasispad cover includes an adhesive for attaching the cover to tubing of thebutterfly needle, and the hemostasis pad cover is arranged such that theportion that covers the hemostasis pad is removed as the needle isremoved from the patient access, thereby exposing the hemostasis pad toblood from the patient access.
 13. A needle assembly comprising: abutterfly needle having a tip, a hub with a pair of wings extendingradially therefrom, and tubing extending from the hub and in fluidcommunication with the tip; and a bandage for securing the butterflyneedle to a patient access site when the needle is inserted therein, thebandage having: a first end region with a first adhesive on at least aportion thereof and a hemostasis pad; a second end region without anyadhesive; a middle region arranged between the first and second endregions, the middle region being releasably connected to the pair ofwings by a second adhesive on at least a portion of the middle region;and wherein the first end region is arranged for contact with thepatient's skin with the hemostasis pad adjacent to a patient access sitewhen the butterfly needle is inserted into the patient access site. 14.The needle assembly of claim 13, wherein the second end and middleregions are arranged such that the middle region can be disconnectedfrom the pair of wings when the butterfly needle in inserted into thepatient access site by pulling on said second end region.
 15. The needleassembly of claim 13, wherein the bandage is configured such that thefirst end region remains connected to the patient's skin with thehemostasis pad adjacent to the patient access site when the butterflyneedle is removed from the patient access site.
 16. The needle assemblyof claim 13, wherein the butterfly needle is only connected to thebandage in said middle region.
 17. The needle assembly of claim 13,further comprising a needle guard movably coupled to said tubing, theneedle guard having a locking portion, wherein the tip of said butterflyneedle is fully contained within the needle guard when the wings of theneedle are moved into said locking portion.
 18. The needle assembly ofclaim 17, wherein the needle guard includes a finger guard arranged suchthat pressure can be applied to the patient access site by pressing onthe finger guard during removal of the butterfly needle from the patientaccess site.
 19. The needle assembly of claim 18, wherein the fingerguard is releasably attached to the needle guard.
 20. The needleassembly of claim 18, wherein the finger guard is releasably attached tothe needle guard by a piece of tape. 21-50. (canceled)